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Targeted Next-generation Sequencing and Bioinformatics Pipeline to Evaluate Genetic Determinants of Constitutional Disease
Published on: April 4, 2018
Patents in genomics and human genetics
Robert Cook-Deegan1, Christopher Heaney
1Institute for Genome Sciences and Policy, Duke University, Durham, NC 27708, USA. gelp@duke.edu
Patents on genetic testing methods hinder innovation, unlike those for medical devices and therapies. Future patent law may limit broad claims impacting whole-genome sequencing.
Area of Science:
- Genomics and human genetics
- Biotechnology
- Pharmaceuticals
Background:
- Genomics and human genetics are foundational scientific fields with significant commercial value.
- Growth in these fields has been fueled by increased funding from government, non-profit, and private sectors, particularly in biotechnology and pharmaceuticals.
- Patents on DNA technologies are integral to the development and commercialization of genomic innovations.
Purpose of the Study:
- To analyze the impact of patent law on emerging genomic technologies.
- To evaluate the role of patents in fostering or impeding research and development in genomics and genetic testing.
- To examine the implications of patent law for future genomic applications like whole-genome sequencing.
Main Methods:
- Review of patent law and its application to genomic technologies.
- Analysis of case studies involving patents in instrumentation, therapeutic proteins, and clinical genetic testing.
- Examination of trends in patent jurisprudence related to genomics.
Main Results:
- Patents on instrumentation and therapeutic proteins have generally supported investment and development.
- Patents on methods and DNA sequences for clinical genetic testing have presented challenges and impediments, often linked to exclusive university licensing.
- Whole-genome sequencing faces potential patent infringement uncertainties, though legal trends suggest narrower claim enforcement.
Conclusions:
- Patent law's effectiveness varies across different areas of genomic technology.
- Exclusive licensing practices in academia can create barriers to genetic testing innovation.
- Evolving jurisprudence may mitigate risks associated with broad patent claims in the era of whole-genome sequencing.
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